RFK’s push for food safety reform: experts analyse the debate over GRAS

RFK Jr. seeks to address loopholes in the GRAS system, aiming for greater FDA oversight of food safety.

Robert F. Kennedy Jr.’s administration has signalled a strong interest in reforming the Generally Recognised as Safe (GRAS) process, a long-debated regulatory framework for food additives. Recent reports indicate that Kennedy has met with food industry leaders and consumer advocates to discuss potential changes, particularly addressing loopholes that have allowed companies to bypass FDA oversight. As the administration explores its next steps, experts weigh in on what these reforms could mean for food safety regulations and industry practices.

Dr. Darin Detwiler, a leading authority on food safety policy, professor of food policy at Northeastern University, and former USDA and FDA advisor, has spent decades advocating for stronger food safety measures. He joins David Acheson, President and CEO of The Acheson Group, to provide insight into the challenges and potential outcomes of reforming the GRAS system.

The current GRAS framework

David Acheson explains that while certain aspects of the GRAS process involve FDA oversight, others do not. Under the current system, food companies can choose to submit a GRAS notification to the FDA, providing a detailed scientific dossier outlining the safety of a substance, its intended use, and potential risks. The FDA then reviews the submission and determines whether it agrees with the company’s safety assessment.

However, Acheson highlights that companies can also opt for “self-affirmation,” a process in which they conduct their own safety evaluation without notifying the FDA. “While this should involve the same level of scientific rigour as an FDA submission, there is no requirement to share the results or even inform the FDA that such an assessment has been conducted,” he notes. “While this should involve the same level of scientific rigour as a submission to FDA, there is no requirement to share the self-affirmation result with FDA or even to inform FDA that such a process has been undertaken. This is the loophole that many critics, including RFK, are likely targeting.”

Potential regulatory changes

Acheson outlines three possible regulatory approaches that RFK’s administration could pursue:

Requiring FDA oversight of self-affirmed GRAS substances: The most immediate step would be mandating that all substances deemed safe through self-affirmation undergo official FDA review. Acheson notes “If this were to happen, there will be a flood of applications heading to FDA, and FDA will need to have the resources to undertake the reviews in a timely manner.”

Reviewing pre-1958 GRAS substances: Many substances that were in use before 1958 were grandfathered into the GRAS system without undergoing modern scientific scrutiny. Acheson suggests that RFK could initiate a review of these substances to reassess their safety in light of new research and potential risks.

Eliminating GRAS in favour of a standardised approval process: A more aggressive approach would be requiring all food substances to go through the FDA’s formal food additive approval process. “This would be the most risk-averse option,” Acheson says, “but it would also demand significantly more FDA resources and could slow down food innovation.”

While it remains unclear which path RFK will take, Acheson believes banning self-affirmation is the most likely first step. “It’s a logical starting point, but it will undoubtedly create bottlenecks in the food industry as companies work to comply with stricter regulations.” Acheson also cautions, “Time will tell just how far this will go and how much of a bottle neck it will create to the food industry, related to the continued use of ingredients currently used under GRAS self affirmation.”

Strengthening the GRAS system: Dr. Darin Detwiler’s perspective

Dr. Darin Detwiler argues that while the focus on specific chemicals and additives is important, a more comprehensive approach is needed. “America’s new Secretary of Health and Human Services – the agency within which the Food and Drug Administration (FDA) sits – recently sat down with representatives from various major food companies to talk. While the conversation could have been more focused on food safety, they did talk at length about the Generally Regarded As Safe (GRAS) program.”

He stresses that the priority should be strengthening the GRAS system as a whole to prioritise consumer safety. “Should we be talking about chemicals and additives and artificial dyes in our food? Yes. 100 percent. However- If we were to talk about fixing a system as a whole, perhaps we could consider root cause analysis and focus on how to make it stronger and to prioritize consumer safety.”

Detwiler proposes several key reforms: “Companies should be required to notify the FDA before marketing any GRAS substance, ensuring public and regulatory awareness.” He advocates for “third-party, independent scientific panels with no financial ties to the industry” to evaluate safety, rather than relying on company-funded experts. “GRAS determinations should be transparent and publicly available, allowing scientists, advocacy groups, and consumers to review the evidence.”

To address outdated safety assumptions, Detwiler suggests a “sunset clause” requiring “all GRAS ingredients should be re-evaluated every 15 – 20 years based on newer scientific methods and data. If concerns arise, the FDA should have the authority to revoke GRAS status.” Finally, he emphasises that “The FDA should have clear enforcement authority to investigate potentially harmful GRAS substances and remove them from the market more easily.”

“Personally, I wish for ALL food to be generally regarded as safe.”